Welcome, Guest. Please login or register.
July 22, 2019, 06:29:59 pm

Login with username, password and session length


Members
Stats
  • Total Posts: 54231
  • Total Topics: 4584
  • Online Today: 64
  • Online Ever: 1314
  • (June 22, 2016, 05:23:42 am)
Users Online
Users: 1
Guests: 56
Total: 57

Welcome

Welcome to the Hep Forums, a round-the-clock discussion area for people who have Hepatitis B, C or a co-infection, their friends and family and others with questions about hepatitis and liver health. Check in frequently to read what others have to say, post your comments, and hopefully learn more about how you can reach your own health goals.

Privacy Warning: Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.
  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.
  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.
  • Product advertisement (including links); banners; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from the Hep Forum Moderators.
Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: Intercept’s Drug for NASH Performs Well Enough for FDA Submission  (Read 910 times)

0 Members and 1 Guest are viewing this topic.

Offline Hep Editors

  • Member
  • Posts: 621
    • Hep Mag
An advanced trial of Intercept Pharmaceuticals’ experimental non-alcoholic steatohepatitis (NASH) treatment found it improved liver fibrosis with no worsening of NASH among participants. The company plans to submit its application for approval of the treatment, obeticholic acid (OCA), to the Food and Drug Administration (FDA) during the second half of 2019.

The Phase III REGENERATE study is a randomized, double-blind placebo-controlled multicenter trial evaluating the safety and efficacy of OCA among 931 people with Stage 2 or 3 liver fibrosis due to NASH. For the FDA to consider the treatment successful, OCA needed to have achieved at least one of two endpoints after 18 months: 1) a one-stage improvement in fibrosis with no worsening of NASH; or 2) a resolution of NASH with no worsening of fibrosis.

Read more...
https://www.hepmag.com/article/intercepts-drug-nash-performs-enough-fda-submission

 


© 2019 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.